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A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

NCT01810653 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2015-08-13

No results posted yet for this study

Summary

The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.

Conditions

Interventions

DRUG

Macrogol (Transipeg, BAY81-8430)

Up to 4 sachets per day based on individual titration

DRUG

Macrogol (Forlax)

Up to 4 sachets per day based on individual titration

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810653 on ClinicalTrials.gov